The invention relates to a method for treating a patient comprising the administration of a blood coagulation factor. The invention further relates to a pharmaceutical composition comprising at least one blood coagulation factor.
It is known in trauma medicine that life-threatening internal bleeding may occur as a consequence of complex pelvic traumata. A complex pelvic trauma involves pelvic fractures complicated by pelvic and extra-pelvic secondary injuries, which is the case at regular intervals. The most common cause of injuries of this kind are accidents involving a massive physical impact of some sort, and therefore most patients are also severely traumatized. Literary sources put the fatality rate associated with complex pelvic injuries as high as 80%. The common cause of death in the early stages is a hemorrhagic shock due to internal bleeding, usually from the Arteria Iliaca, the sacral vein plexus and/or the spongy bone areas of the fractured pelvic ring. Blood may freely flow into the pelvic cavity, since the building up of a counter pressure that would cause a so-called “Own Tamponade” does usually not take place.
Most writers do not recommend exploring a pelvic haematoma with an intact peritoneum. The most important therapeutic concept consists therefore of a primary stabilization of the pelvic fracture in order to attain a compression effect and effectively restrict bleeding from the spongy bone areas. Erythrocyte concentrate (EC) is administered to compensate for the blood loss.
If an increase in the volume of the hematoma is observed during a monographic development check, the most likely reason lies with an arterial injury. Under these circumstances, Own Tamponade has proven ineffective because of the completely ruptured vascular walls. Direct hemostasis is not usually useful because of the time required and the multiple sources of bleeding. The temporary clamping of the aorta is effective, but hardly applicable or to be preferred. Not enough clinical data are available for pelvic slings and pelvic belts.
Catheter embolization is frequently described as an efficient procedure. This procedure involves the selective occlusion of the ruptured vessels by purposely introducing emboli via an arterial catheter by interventional radiology. A localization of the bleeding by angiography is necessary before the procedure. It requires a high degree of skill on the part of the responsible radiologist and even in the hands of an experienced person it requires a very large amount of time to carry out. This constitutes a severe drawback in the emergency treatment. Despite its increasing availability in many clinics, angiography usually takes place five to seventeen hours after admission, according to the literature on the subject. The average requirement of EC is given as 1.2/h, while patients who are being treated with the pelvic clamp or pelvic tamponade require an average EC amount of 2.8/h to 8/h. The angiographic method of haemostasis in patients with unstable pelvic injuries and accompanying circulation instability should therefore be confined to patients with persistent pelvic bleeding whose circulation has been able to be stabilized through adequate volume therapy. Excepted are so-called borderline patients with severe trauma (ISS>20 and additional thorax trauma, multiple trauma with abdominal/pelvic trauma and hemorrhagic shock [initial RR<90 mmHg]; or ISS≧40 without additional thorax injuries, bilateral lung contusions in the primary thorax X-ray) and patients in extremis with acute danger of exsanguination.